Last reviewed · How we verify
Diovan (VALSARTAN)
Diovan works by blocking the action of angiotensin II, a hormone that constricts blood vessels and increases blood pressure.
Valsartan (Diovan), marketed by Novartis, is a leading angiotensin II receptor blocker primarily indicated for chronic heart failure in adults. Its key strength lies in its well-established mechanism of action and strong brand recognition, with a key composition patent expiring in 2028. The primary risk is the intense competition from off-patent same-class drugs such as losartan, eprosartan, irbesartan, candesartan cilexetil, and telmisartan, which are widely available as generics.
At a glance
| Generic name | VALSARTAN |
|---|---|
| Sponsor | Novartis |
| Drug class | Angiotensin 2 Receptor Blocker [EPC] |
| Target | Type-1 angiotensin II receptor |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1996 |
| Annual revenue | 447 |
Mechanism of action
Angiotensin II is formed from angiotensin in reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Valsartan tablets blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis.There is also an AT2 receptor found in many tissues, but AT2 is not known to be associated with cardiovascular homeostasis. Valsartan has much greater affinity (about 20,000-fold) for the AT1 receptor than for the AT2 receptor. The increased plasma levels of angiotensin II following AT1 receptor blocka
Approved indications
- Chronic heart failure in adults
- Symptomatic heart failure in pediatric patients
Boxed warnings
- WARNING: FETAL TOXICITY When pregnancy is detected, discontinue ENTRESTO as soon as possible (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue ENTRESTO as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )
Common side effects
- Dry cough
- Dizziness
- Viral infection
- Fatigue
- Abdominal pain
- Headache
- Upper respiratory infection
- Diarrhea
- Rhinitis
- Sinusitis
- Nausea
- Pharyngitis
Drug interactions
- aliskiren
- ACE inhibitor
- ARB (Angiotensin II Receptor Blocker)
- potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
- potassium supplements
- salt substitutes containing potassium
- NSAIDs (Nonsteroidal Anti-Inflammatory Drugs)
- lithium
Key clinical trials
- Efficacy and Safety of Sacubitril/Valsartan in African American Patients With Heart Failure With Reduced Ejection Fraction
- Manganese-enhanced Magnetic Resonance Imaging in Takotsubo Cardiomyopathy (NA)
- Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 3 (PHASE4)
- Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan (PHASE1,PHASE2)
- A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction (PHASE1)
- A Real-world Study of Clinical Treatment Guidelines for Patients With Heart Failure With Reduced Ejection Fraction Treated With Sacubitril/Valsartan
- A Real-world Study of the Effectiveness of Angiotensin Receptor-Neprilysin Inhibitor Therapy in Hypertensive Patients in the United Arab Emirates
- The ENCHANTMENT HIV Study (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Diovan CI brief — competitive landscape report
- Diovan updates RSS · CI watch RSS
- Novartis portfolio CI